Clinical Research Coordinator 1/2, Pediatrics

About the role

The Department of Pediatrics at the University of Virginia School of Medicine is seeking a Clinical Research Coordinator 1 or 2 (CRC 1-2), Non-Licensed to support clinical research conducted by the Pediatrics Department Chair and other faculty within the Department as needed.

Responsibilities

• Assist with the day-to-day coordination of clinical research studies and work closely with Principal Investigators and other study team members.
• Support study start-up activities, including collection and preparation of regulatory documents, study materials, and other required documentation.
• Aid in the creation and maintenance of study tools, including visit schedules, source documents, participant diaries, study checklists, training logs, equipment records, and study communications.
• Support participant recruitment efforts, including identification and pre-screening of potential research participants.
• Aid in screening and enrollment activities and, following appropriate training and authorization, participate in the informed consent process.
• Care for participant study visits and protocol-required activities, including scheduling appointments and procedures and communicating with participants and members of the clinical care team.
• Collect and maintain accurate research data and source documentation in accordance with study protocols, institutional policies, and Good Clinical Practice (GCP).
• Enter and maintain study data in internal and external electronic data capture systems and respond to data queries with guidance from senior research staff.
• Aid in the collection, processing, preparation, storage, and shipment of research specimens according to study protocols and applicable requirements.
• Maintain study records, participant tracking logs, regulatory documents, and other essential research documentation.
• Aid in tracking concomitant medications, adverse events, protocol deviations, and other study-related information and promptly communicate concerns to the Principal Investigator and/or supervising research staff.
• Support preparation and submission of materials to the Institutional Review Board (IRB) and other regulatory or oversight bodies as appropriate.
• Aid in sponsor and CRO monitoring visits, site initiation visits, audits, and other study-related meetings and activities.
• Communicate professionally with study participants, investigators, sponsors, CROs, clinical teams, and other departments involved in research activities.
• Aid in tracking participant payments and research-related clinical activities and charges.
• Develop proficiency in clinical research systems used by UVA and external sponsors, which may include Epic, OnCore, IRB Pro, Protocol Builder, REDCap, iMedidata, Inform, OpenClinica, and other electronic data capture and study-management systems.
• Develop knowledge of federal regulations, institutional policies, Good Clinical Practice, and other requirements governing the conduct of human subjects research.
• Perform other duties as assigned.

Qualifications

• CRC 1 non-licensed: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
• CRC 2 non-licensed: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Pay

• CRC 1 non-licensed: Anticipated hiring range: $25-27 hourly (non-exempt), commensurate with education and experience.
• CRC 2 non-licensed: Anticipated hiring range: $60,000-65,000 annual (exempt), commensurate with education and experience.